A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants

doi:10.1067/S0022-3476(03)00301-9

The Journal of Pediatrics

Volume 143, Issue 5, November 2003, Pages 582-586

https://doi.org/10.1067/S0022-3476(03)00301-9 Get rights and content

Abstract

Objectives

To test whether iron supplementation affects hematologic, biochemical, and developmental status in term breast-fed infants.

Study design

Term breast-fed infants (n = 77) were randomly selected to receive either 7.5 mg per day of elemental iron as ferrous sulfate or placebo from 1 to 6 months of age. Investigators and families were unaware of group assignment. Complete blood count and ferritin, red cell superoxide dismutase, catalase, plasma ferric reducing antioxidant power, and zinc and copper levels were analyzed at 1, 3.5, 6, and 12 months of age. Bayley mental and psychomotor developmental indexes (MDI and PDI) and visual acuity (with the use of Teller acuity cards) were assessed from 12 to 18 months of age. Analysis performed by analysis of variance and t tests was by intention to treat.

Results

Iron supplementation resulted in higher hemoglobin and mean corpuscular volume at 6 months of age and significantly higher visual acuity and PDI at 13 months of age (100±12 vs 93±9 [±SD]). Treatment and placebo groups did not differ in anthropometric indexes, compliance, biochemical status, or demographic characteristics.

Conclusions

Iron supplementation of breast-fed infants appears safe and might have beneficial hematologic and developmental effects for some infants.

Section snippets

Methods

Between January 1999 and August 2000, mother-infant dyads were approached in the regional postpartum unit in St John's, Newfoundland, for informed consent to enter this study. The primary requisite for inclusion was an intent to breast-feed exclusively (with no more than one supplemental feed per day for at least 4 months), as per recommendations.¹¹ Exclusion criteria included gestation <37 weeks, birth weight <2.5 kg, multiple pregnancy, major illness requiring intensive care admission, and

Results

Both groups were similar at study entry (1 month) with respect to birth weight, gestation, length, head circumference, and HGB and FRT levels (Table I, Table II). No significant difference was noted between treatment and placebo groups in maternal (52±16 vs 55±20) or paternal (50±15 vs 51±13) socioeconomic status, maternal age (31±4 vs 31±4 years), number of children in the household (1.6±0.7 vs 1.7±0.7), or maternal prepregnancy weight (151±30 vs 138±24 lbs).

Discussion

Our data suggest that iron supplementation of exclusively breast-fed term infants prevents the natural fall in HGB that occurs from 1 to 6 months of age. These results are similar to those reported in Swedish and Honduran infants given iron supplements from 4 to 6 months of age.¹³ In the current study, breast-fed infants who received iron demonstrated improved PDI and visual acuity at 13 months of age. Results for growth between groups in the current study did not differ at any time in contrast

Acknowledgements

We acknowledge the families and children who volunteered for the study; Renu Gill, Pharmacist, and the Pharmacy of the Janeway Children's Health and Rehabilitation Center, St John's, Newfoundland; Claude Mercer and Allison McDonald, Research Assistants; the Child and Women's Health Programs and Laboratory Staff of the Health Care Corporation of St John's; the Janeway and General Hospital Foundations, St John's, Newfoundland.

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^☆

Supported by the Canadian Institutes of Health Research and the Janeway Research Foundation.

There was no potential, perceived, or real conflict of interest in this study.

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A double-masked, randomized control trial of iron supplementation in early infancy in healthy term breast-fed infants☆

Abstract

Objectives

Study design

Results

Conclusions

Section snippets

Methods

Results

Discussion

Acknowledgements

J Pediatr

Early Hum Dev

Am J Clin Nutr

J Pediatr

Methods Enzymol

J Pediatr

Vision Res

Lancet

J Nutr

J Pediatr

Incidence of iron-deficiency anemia and depleted iron stores among nine-month-old infants in Vancouver, Canada

Can J Public Health

An evaluation of full-term infants fed an evaporated milk formula

Acta Pediatr Scand

Iron status in exclusively breast-fed infants

Pediatrics

Levels of serum ferritin and total body iron among infants with different feeding regimens

Acta Pediatr Japn

Poorer behavioral and developmental outcome more than 10 years after treatment for iron deficiency in infancy

Pediatrics

A review of studies on the effect of iron deficiency on cognitive development in children

J Nutr

Influence of lactoferrin on iron absorption from human milk in infants

Pediatr Res